Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause

This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of Menopause.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Vaginal Atrophy; Vaginal Dryness; Dyspareunia; Chronic UTI
• Intervention / Treatment: Device: Hybrid Fractional Laser

Detailed Description

Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue health may lead to improvement of symptoms of Genitourinary Syndrome of Menopause (GSM). This multi-centered, 18-month prospective clinical trial will evaluate the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (HFL) as an alternative non-surgical, non-hormonal treatment for symptoms of GSM.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Gatos, California, United States, 95032
      • Women's Pelvic Health Institute
  • Florida
    • Pensacola, Florida, United States, 32514
      • Coyle Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Carolinas Healthcare System
  • Texas
    • The Woodlands, Texas, United States, 77384
      • Woodlands Gynecology & Aesthetics
  • Virginia
    • North Chesterfield, Virginia, United States, 23235
      • The Female Pelvic Medicine Institute of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Healthy biological female aged between 40 to 70 years

2. Is post-menopausal with a AND b OR c

   1. No menses for at least 12 months
   2. Follicle-stimulating hormone (FSH) level over 40mlU/mL
   3. Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement

3. Is experiencing at least two self-reported symptoms of GSM, such as

   1. Vaginal irritation in absence of infection
   2. Chronic burning sensation
   3. Chronic itching in the absence of infection
   4. Recurring urinary tract infections (UTIs)
   5. Vaginal dryness during sexual activity
   6. Pain during sexual activity (dyspareunia)
4. Has been experiencing symptoms of GSM for greater than 3 months
5. Is unable due to medical contraindication or unwilling to receive hormone-based vaginal therapy
6. Normal and up-to-date pap smear if applicable
7. Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve
8. Can read, understand and sign informed consent form

Exclusion Criteria:

1. Undiagnosed abnormal genital bleeding
2. Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
3. Previous use of topical estrogen therapy within the last 3 months
4. Has used vaginal creams, moisturizers, lubricants or homeopathic preparations or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment
5. History of heart failure
6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q)
7. Has an active sexually transmitted infection (STI)
8. Has signs or symptoms of vaginitis/vulvitis
9. Has signs or symptoms of acute urinary tract infection (UTI)
10. Has participated in any clinical trial involving an investigational drug or procedure within the past 30 days
11. The investigator feels that for any reason the subject is not eligible to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hybrid Fractional Laser; Hybrid fractional 2940 nm and 1470 nm laser treatment	Device: Hybrid Fractional Laser; Consecutive and coincident fractional 2940 nm and 1470 nm lasers; Other Names: diVa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Vaginal Maturation Index (VMI)	An objective assessment of vaginal hormone response as well as overall hormonal environment by calculating a ratio of parabasal cells, intermediate cells, and superficial cells	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Histology	Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.	12 months
Change from baseline in Vaginal Health Index Score (VHIS)	A quantitative assessment of vaginal health that evaluates vaginal elasticity, fluid volume, pH, epithelial integrity, and moisture on a scale of 1 to 5.	12 months
Change from baseline in Female Sexual Function Index (FSFI)	A multidimensional self-report instrument for assessment of female sexual function.	12 months
Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA)	A multidimensional self-report measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women.	12 months
Change from baseline in Clinical Photography	Change from baseline in the appearance of the treatment area.	12 months

Collaborators and Investigators

• Sponsor: Sciton
• Investigators: Principal Investigator: Nathan Guerette, MD, The Female Pelvic Institute of Virginia

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2017
• Primary Completion (ACTUAL): February 25, 2020
• Study Completion (ACTUAL): February 25, 2020

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (ACTUAL): June 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Dyspareunia
• Other Study ID Numbers: DIVACIP002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes